Registry provides real world data on TAVR procedures

The Nov. 30 release of data from a transcatheter aortic valve replacement (TAVR) registry provided clinicians, patients and payers with robust, real world information on a procedure that’s becoming more popular.

In December 2011, the Society of Thoracic Surgeons and the American College of Cardiology worked in collaboration with the Centers for Medicare & Medicaid Services (CMS) to launch the Transcatheter Valve Therapies (TVT) registry. They wanted to monitor the safety and efficacy of TAVR devices.

In 2014, 348 centers performed TAVR procedures, up from 156 in 2012 and 252 in 2013. As of the end of last year, the registry included data on 26,414 patient records and all of the major devices at the time, including the Sapien (Edwards Lifesciences) and CoreValve (Medtronic).

So far, patient outcomes have been “extremely encouraging,” according to Michael J. Reardon, MD, and Neal S. Kleiman, MD, who wrote an editorial comment in the Journal of the American College of Cardiology on the day the data were released online.

Reardon and Kleiman, who were involved in TAVR clinical trials, noted that the devices were implanted successfully in 97.4 percent of procedures in 2014. They also cited the low rates of mortality (4.4 percent), MI (0.4 percent), renal injury stage 3 (2.2 percent) and stroke (2.2 percent).

Further, they mentioned that fewer extremely high-risk individuals and more intermediate- to high-risk patients are undergoing TAVR.

Reardon and Kleiman said that the TVT registry played a major role in CMS approving direct aortic access for TAVR. The registry will also provide long-term data on TAVR devices and help payers and clinicians understand the relationship between operator experience, institutional volume and successful procedures.

“Important questions remain to be resolved, particularly in regard to antithrombotic therapies, in patients who have undergone TAVR,” Reardon and Kleiman wrote. “Use of the registry is likely to become a useful mechanism to resolve these questions in a broad national population.”